Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott 

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: 

Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.  A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.  

The Opportunity

This position works out of our Austin, Texas location in the in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

This position is responsible directly and through subordinate managers to oversee all operations engineering activities at a third-party manufacturer. The position will ensure that products are manufactured consistently based on Abbott quality standards to meet market demands. The position will be accountable for a large installed base of advanced automation and the processes that support it at an Abbott TPM.

What You’ll Work On 

 Serve as the QA representative on on-market development / change teams.

Monitor design control related projects.Project planning issuesCompliance Activities (DHF Audits, Traceability, etc.)Verification and Validation StatusParticipate in continuous improvement initiatives as appropriate for the design control system.Build and maintain successful cross functional relationships with internal departments such as R&D Engineering, Operations, Quality and Regulatory Affairs.Provide support, as needed, to Clinical Material Release, Quality Control, and Calibration programs.

MAIN RESPONSIBILITIES

• Assist in the development, approval, and change control of design history documentation (e.g. Design Inputs, Design Outputs, Trace Matrix, Design Verification/Validation,Change Impact Assessments, Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.)

• Monitor and maintain DHF requirements in accordance with project timeline and design control requirements.

• Actively engage with Operations and Engineering to implement design control deliverables.

Required Qualifications 

B.S in Engineering, Life Sciences, or Physical SciencesMinimum 2 years Quality Assurance,Technical Quality, or equivalent.Knowledge in the areas of Design Controls, VV activities, manufacturing practices or processes, and statistical techniques.Working knowledge applicable regulations and standards such as FDA, QSR and ISO regulations.Demonstrated written, oral and interpersonal skills.Strong analytical skills, problem solving techniques and statistical application experience.

Apply Now 

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com  

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. 

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. 

The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.